Open-label Study to Evaluate Clearance of Superficial Basal Cell Carcinoma After Use of Imiquimod 5% Cream

This study has been completed.
Sponsor:
Information provided by:
Graceway Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00189306
First received: September 13, 2005
Last updated: August 5, 2010
Last verified: August 2010
  Purpose

An open-label study to evaluate the safety and the ability of Imiquimod 5% cream, applied topically, to clear superficial basal cell carcinoma and to keep it clear for 5 years of follow-up.


Condition Intervention Phase
Superficial Basal Cell Carcinoma
Drug: Imiquimod 5% cream
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Study to Evaluate the Safety and Long-Term Clinical Efficacy of Imiquimod 5% Cream Applied Once Daily 7 Days Per Week for 6 Weeks in the Treatment of Superficial Basal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Graceway Pharmaceuticals, LLC:

Primary Outcome Measures:
  • Number of Participants With Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Number of participants clinically clear of superficial basal cell carcinoma at the treated target tumor site at the 12-week posttreatment visit (ie, initial clearance rate) who remain clear during a 5 year follow-up period.


Secondary Outcome Measures:
  • Number of Participants Cleared of Superficial Basal Cell Carcinoma at 12 Weeks [ Time Frame: 12 week posttreatment visit ] [ Designated as safety issue: No ]
    Number of participants cleared at 12 weeks(the number of subjects with no clinical evidence of superficial basal cell carcinoma at the target tumor site at the 12-week posttreatment visit)


Enrollment: 169
Study Start Date: March 2001
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aldara
Aldara (imiquimod) cream 5% applied 7 times per week for 6 weeks
Drug: Imiquimod 5% cream
Aldara (imiquimod) 5% cream - 250 mg / packet - once daily 7 days per week for 6 weeks
Other Name: Aldara (imiquimod) 5% cream - 250 mg / packet

Detailed Description:

Evaluate the long-term sustained clearance rate, defined as the proportion of those subjects clinically clear of basal cell carcinoma (BCC) at the treated superficial BCC (sBCC) target tumor site at the 12-week posttreatment visit who remain clear during a 5 year follow-up period.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have at least 1 previously untreated superficial basal cell carcinoma tumor
  • Minimum tumor size 0.5 cm2 and maximum diameter of 2.0 cm

Exclusion Criteria:

  • Evidence of clinically significant, unstable medical conditions
  • Cannot have recent use of topical steroids or retinoids in the treatment area.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189306

Locations
Australia, New South Wales
Medical Centre, Concord Hospital
Concord, New South Wales, Australia
Prince of Wales Hospital
Randwick, New South Wales, Australia
Australia, Queensland
Skin Centre
Benowa, Queensland, Australia
South East Dermatology Centre
Carina Heights, Queensland, Australia
105 Fulham Road
Gulliver, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Australia, South Australia
Flinders Medical Center
Bedford Park, South Australia, Australia
Queen Elizabeth Hospital
Woodville, South Australia, Australia
Australia, Victoria
Western Hospital
Footscray, Victoria, Australia
Austin & Repartriation Hospital
Heidelburg, Victoria, Australia
Australia, Western Australia
Freemantle Dermatology
Fremantle, Western Australia, Australia
158 South Terrace
Perth, Western Australia, Australia
Subiaco Clinic
Subiaco, Western Australia, Australia
New Zealand
103A Mountain Road
Epsom, Auckland, New Zealand
Birthcare Building
Parnell, Auckland, New Zealand
Dermatology Practice
Christchurch, New Zealand
Colombo Mansions
Christchurch, New Zealand
Skin Institute Limited
Takapuna, New Zealand
Sponsors and Collaborators
Graceway Pharmaceuticals, LLC
Investigators
Study Director: Jim Lee, Dr. Graceway Pharmaceuticals
  More Information

Publications:
Responsible Party: Medical Director, Graceway Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00189306     History of Changes
Other Study ID Numbers: 1413-IMIQ
Study First Received: September 13, 2005
Results First Received: October 30, 2008
Last Updated: August 5, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Graceway Pharmaceuticals, LLC:
Superficial Basal Cell Carcinoma
Aldara

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Neoplasms, Glandular and Epithelial
Imiquimod
Adjuvants, Immunologic
Antineoplastic Agents
Immunologic Factors
Interferon Inducers
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014